NCT04986657NARecruitingAccepts Healthy Volunteers
Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Washington University School of Medicine
Start Date
9/17/2021
Completion Date
12/31/2027
Summary
This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria Patient
* Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested.
* Adult patients 18 years or older.
* Ability to understand and willingness to sign an IRB approved written informed consent document.
Inclusion Criteria Physician
* Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.
* Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process.
Exclusion Criteria Patient
* Younger than 18 years of age
Exclusion Criteria Physician
* Does not treat patients at Washington University School of Medicine
Interventions
DEVICE
ChromoSeq
Conditions
Whole Genome SequencingAcute Myeloid LeukemiaMyelodysplastic Syndromes
Locations
Washington University School of Medicine
St Louis, Missouri 63110
United States